1Quality unit oversight
The annual product quality review procedure was inadequate. The quality control department did not evaluate the results of the annual product quality review.
Inspection Record
Ani Pharmaceuticals Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
3Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
4Other quality system
Yields and/or the reconciled quantities were not checked at appropriate stages.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
7Other quality system
The written self-inspection procedure was inadequate. The implementation of a self-inspection program was inadequate.
8Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-01-11. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
